Background Vaccination is one of the most cost-effective public health interventions available and the main tool for primary prevention of communicable diseases. However, the EU is facing increasing outbreaks of vaccine preventable diseases, while some fatal cases of measles and diphtheria have been reported. Methods The presented report is based on the work of the Expert Panel on effective ways of investing in Health, which was informed by a literature review on the main factors (enablers and obstacles) influencing vaccination uptake. Results Obstacles to vaccination coverage include individuals’ and parents’ concerns or fears about vaccine safety and side effects, lack of trust, social norms, exposure to rumours and myths undermining confidence in vaccines, failure by some healthcare providers to counter these myths and provide evidence-informed advice, access barriers (e.g. poor availability, co-payments), and failure to understand the underlying mechanisms that decrease vaccination confidence. Enablers include sources of reliable information about vaccination, exposure to positive media messages, building trust in institutions and providers, building confidence in vaccination, easy access and availability to healthcare services, ease of administration, active involvement and engagement by healthcare providers, and targeting of high-risk groups. Conclusions There is a range of policy options that countries can implement to increase vaccination coverage. Communication strategies about the benefits of vaccination are important but need to be combined with opportunities for dialogue with vaccine hesitant groups and participatory approaches. These strategies need to be targeted not only at the uninformed (i.e. the lack of information) but also at the misinformed (when the information is incorrect) or disinformed (when information is spread with the intention to deceive).
IntroductionEvidence synthesis (ES) is often required for economic evaluation (EE) of pharmaceuticals. Commonly used methods are based on the assumption of proportional hazards in trial data, using the hazard ratio (HR). Alternative methods for ES are increasingly used in EE, in situations where the pattern of hazards in the trial data indicates that the proportional hazards assumption may be violated. The impact of these methodological choices on model outcomes is explored.MethodsA network of trials of BRAF-targeted treatments for advanced melanoma, derived using a systematic review of the literature, is chosen for the study. Guyot's method is used to create individual-patient Kaplan-Meier (K-M) data from published survival curves. Log-cumulative hazard plots and Schoenfeld residuals are derived to examine patterns in hazards within the trial data. All analyses are conducted in R version 3.5.0©. Three alternative methods for ES are tested: 1) Network meta-analysis (NMA) based on published HRs and the assumption of proportional hazards. 2) NMA using fractional polynomials (FP) based on digitised K-M data, allowing the relaxation of the proportional hazards assumption. 3) NMA using an accelerated failure time (AFT) model based on digitised K-M data, allowing the relaxation of the proportional hazards assumption. The derived estimates of relative efficacy from each method are applied in a partitioned survival cost-effectiveness model programmed in Microsoft Excel™.ResultsThe model outcomes predicted by each method (HR, FP and AFT) are presented and compared. Both deterministic and probabilistic results are presented, alongside a discussion around how the uncertainty in these structural assumptions may be captured in EE.ConclusionsStructural assumptions in ES may lead to differences in model outcomes. The impact of these differences may be important in situations where decision uncertainty is high. Methods should be chosen and justified based on patterns of hazard present in the trial data.
IntroductionThere is ongoing debate as to whether conventional pharmacoeconomic evaluation (PE) methods are appropriate for orphan medicinal products (OMPs). The National Centre for Pharmacoeconomics (NCPE) in Ireland has a well-defined process for conducting pharmacoeconomic evaluations of pharmaceuticals, which is the same for OMPs and non-OMPs. The objective of this study was to identify whether supplementary criteria considered in the pharmacoeconomic evaluation of OMPs would affect final reimbursement recommendations.MethodsA literature search was conducted to identify criteria. Orphan drug pharmacoeconomic evaluations completed by the NCPE between January 2015 and December 2017 were identified and supplementary criteria, where feasible, were applied.ResultsFourteen pharmacoeconomic evaluations were included in the study. Three criteria that could feasibly be applied to the NCPE evaluation process were identified, all three of which essentially broadened the economic perspective of the pharmacoeconomic evaluation. Higher cost-effectiveness threshold: Despite being arbitrarily raised from EUR 45,000/QALY to EUR 100,000/QALY, only one orphan drug demonstrated cost-effectiveness at this higher threshold. Weighted QALY gain: here, a weighted gain of between one and three is applied to drugs demonstrating QALY gains between 10 and 30, respectively. No OMPs included in the study showed a QALY gain of more than 10. Thirteen demonstrated QALY gains less than 10 and one could not be evaluated. Societal perspective: six submissions incorporated societal perspective as a scenario analysis. Despite incremental cost-effectiveness ratios (ICERs) being reduced between 4 percent and 58 percent, only two OMPs demonstrated cost-effectiveness at the higher threshold (EUR 100,000/QALY).ConclusionsApplication of supplementary criteria to the pharmacoeconomic evaluation of OMPs had a minor effect on three products assessed. However, for the majority, the final cost-effectiveness outcomes remained the same. The study highlights that other criteria are being considered in the decision to reimburse.
ISBN 978 0 7070 0289 7 ACKNOWLEDGEMENTSFinancial support for this report and two others in the series was provided by the Health Research Board and the Health Service Executive. The authors would like to thank Maura Hiney from the Health Research Board and the members of the Steering Committee for their support, input and encouragement over the life of the project. Valuable comments on the text and helpful suggestions for revision were made by five anonymous external reviewers. We would like to thank these reviewers for their contributions whilst accepting that the authors bear sole responsibility for the analyses and interpretations presented.
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